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Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence

Sponsor
Carilion Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT03831997
Collaborator
(none)
35
Enrollment
1
Location
40.4
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to reduce the recurrence rate of chronic subdural hematomas (CSDH) by manipulating the post-operative intravenous fluid use. The hypothesis relies on the relationship between osmolality and volume changes related to osmolality. We will be administering dextrose 5% in 1/4 normal saline (D5 1/4NS) post-operatively to induce brain expansion which can take up the residual CSDH space, to help reduce recurrence rate.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dextrose 5% W/ Sodium Chloride 0.225%

Detailed Description

Chronic subdural hematoma (CSDH) is a neurological disease characterized by a collection of fluid, blood, and blood degradation matter between the arachnoid and dura mater in a well-developed membrane cavity. The presentation of this disease begins with minor head trauma and takes 4-7 weeks to become symptomatic.

One of the significant problems exists with CSDH is the rate of recurrence, which currently stands at a 7-30% rate worldwide. The recurrence of a CSDH is typically defined as the presence of residual or recurrent CSDH after the first resolution, leading to additional surgical intervention either within 3 months (early recurrence) or after 3 months (late recurrence). Additional surgical intervention (recurrence rate) is the outcome variable that our study will be looking at. Factors leading to persistent recurrence include age, use of anticoagulant therapy, volume of hematoma cavity, degree of midline shift on CT, presence of residual air post-operatively, and volume of residual hematoma fluid. The variability in surgeons' operative and post-operative care, which tries to address the multiple factors that lead to recurrence, illustrates the difficulty in trying to reduce postoperative recurrence. In fact, there is no postoperative standard of care. These variations in operative and postoperative care have yet to significantly decrease the recurrent rate of CSDH.

Given the health status and fragility of the patient population that is most commonly affected by CSDHs, and the inherent morbidity related to operating on this population, we hypothesize that D5 1/4NS can help mitigate the issue of residual/recurrence CSDH leading to subsequent surgeries. The fluid dynamics of D5 1/4NS have been studied and we can assume that it will facilitate brain re-expansion.

Study Design

Study Type:
Observational
Anticipated Enrollment :
35 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
The Effect of Dextrose 5% in 0.225% Sodium Chloride (D5 1/4NS) on Postoperative Chronic Subdural Hematoma Size and Recurrence Rate
Actual Study Start Date :
Jan 17, 2019
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Historical Controls

The retrospective arm will consist of our control group, it will be derived from a retrospective medical chart review of all patients with CSDH at the facility.
Prospective Arm

The prospective arm of the study will be looking at the effects of Dextrose 5% W/ Sodium Chloride 0.225% on the recurrence rate defined by the need for secondary surgical intervention for residual/recurrent CSDH) of CSDH in a 3-month post-operative window.

Drug: Dextrose 5% W/ Sodium Chloride 0.225%
D5 1/4NS is comprised of 5% dextrose in a 0.225% sodium chloride (NaCl) solution. D5 1/4NS is initially slightly hypertonic to plasma, with an osmolarity of 321 mOSm/L. As the glucose component is rapidly metabolized, 0.225% NaCl solution remains and is hypotonic to plasma at an osmolarity of 77 mOsm/L. Because of the hypotonicity of the 1/4NS, it shifts into the intracellular compartments, followed by free water, and allows for volume expansion.
Other Names:
  • D5 1/4NS

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Recurrence Rate [Within 120 days (+/- 7 days) of their initial burr-hole surgery.]

      We will see how many patients who are treated with D5 1/4NS have a recurrent episode of CSDH after their post-operative treatment.

    Secondary Outcome Measures

    1. Rate of Volume Change of Residual CSDH Space [24 (+/- 6 hours) hours post-operative.]

      We will see how fast the brain volume expands after the administration of both NS and D5 1/4NS.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of chronic subdural hematoma (based on imaging)

    • Need for surgical intervention (assessed by attending neurosurgeon based on full neurological assessment)

    • The procedure of choice is burr hole drainage

    • Cessation of anti-coagulant therapy with accompanying normal lab values in appropriate time frames respective to the drug

    • Tolerance of supine position

    Exclusion Criteria:

    • <60 years old

    • Presence of acute hemorrhage, stroke, or parenchymal damage

    • Neurological deficits not accountable to mass effect

    • Hyponatremia or inherent electrolyte imbalances

    • Pregnancy or non-consentable patients

    • Previous neurological surgery up to 1 year before being considered for the study

    • Rapid re-expansion of brain observed intraoperatively by attending neurosurgeon

    • Congestive heart failure or other medical conditions precluding normal postoperative administration of IV fluids

    • Blood glucose levels > 135 mg/dL

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Carilion Roanoke Memorial Hospital Roanoke Virginia United States 24016

    Sponsors and Collaborators

    • Carilion Clinic

    Investigators

    • Principal Investigator: Eric Marvin, DO, Carilion Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Eric A. Marvin, Principle Investigator, Carilion Clinic
    ClinicalTrials.gov Identifier:
    NCT03831997
    Other Study ID Numbers:
    • #2589
    First Posted:
    Feb 6, 2019
    Last Update Posted:
    Oct 8, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Hematoma, Subdural
    Hematoma, Subdural, Chronic
    Recurrence
    Hematoma

    Study Results

    No Results Posted as of Oct 8, 2020